Specialist I, Regulatory Affairs

Sonova AG • Santa Clarita, CA

8d • $79,200 - $94,280 • Hybrid

About The Position

Advanced Bionics is seeking an International Regulatory Affairs Specialist to support regulatory strategies and activities for product approvals and registrations across Middle East and North Africa (MENA) markets. This role is responsible for planning and executing regulatory submissions, maintaining product registrations, supporting regulatory compliance, and partnering with in-country representatives and cross-functional teams to help ensure timely market access and continued product availability.

Requirements

• Bachelor’s degree in a scientific discipline, engineering, or equivalent experience required
• At least 3 years of International Regulatory Affairs experience with a Bachelor’s degree
• Experience with submissions and compliance for Class III medical device companies preferred
• Strong knowledge of regulatory pathways in Middle East and North Africa markets, ISO 14971, ISO 13485, labeling, clinical requirements, and post-market obligations
• Strong communication, critical thinking, organizational, project management, collaboration, and attention-to-detail skills
• Experience with Microsoft Office, Salesforce, SAP, and RIM platforms such as RegDesk or RIMSYS preferred
• A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova

Nice To Haves

• Master’s degree in a scientific discipline, engineering, Regulatory Affairs, or equivalent experience preferred
• At least 5 years with a Master’s degree in a directly related specialty

Responsibilities

• Plan and execute regulatory activities needed to obtain and maintain approvals within Middle East and North Africa (MENA) markets
• Support end-to-end submissions, manage timelines, respond to deficiencies, and partner with in-country representatives as needed
• Provide support to local Regulatory Affairs affiliates who interact with regulatory authorities to help ensure timely approvals and continued product access
• Participate in sustaining and new product development projects by providing MENA regulatory requirements
• Review product changes and assess regulatory impact on submission strategy and market registrations
• Monitor new or amended regulations and support post-market regulatory compliance activities for assigned markets
• Update regulatory information management tools and support Regulatory Affairs procedures and process improvement activities

Benefits

• Medical, dental and vision coverage
• Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
• TeleHealth options
• 401k plan with company match
• Company paid life/ad&d insurance
• Additional supplemental life/ad&d coverage available
• Company paid Short/Long-Term Disability coverage (STD/LTD)
• STD LTD Buy-ups available
• Accident/Hospital Indemnity coverage
• Legal/ID Theft Assistance
• PTO (or sick and vacation time), floating Diversity Day, & paid holidays
• Paid parental bonding leave
• Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)
• Robust Internal Career Growth opportunities
• Tuition reimbursement
• Hearing aid discount for employees and family
• Internal social recognition platform

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level